June 13, 2013

Supreme Court Rules Natural DNA Not Patentable

A unanimous Supreme Court ruled today that "naturally occurring" DNA segments cannot be patented. Justice Clarence Thomas wrote the opinion for the court in Association for Molecular Pathology v. Myriad Genetics. The case was argued on April 15, which means the opinion was a relatively quick turnaround for the court.

The ruling in the closely-watched case is a victory for civil liberties and consumer groups that argued corporations should not be able to lock up the uses of new DNA that could benefit patients if widely available. The Myriad patents at issue in the case were for BRCA1 and BRCA2 gene segments which, when mutated, can increase the risk for breast and ovarian cancer. Myriad developed diagnostic tests from the segments that could reveal cancer risk in women.

Patients challenged the patents in court, and a district court judge ruled they were invalid because they covered products of nature. But the U.S. Court of Appeals for the Federal Circuit reversed.

Thomas' opinion reviewed the science and technology involved in the claim and concluded that while "Myriad found the location" of the genes at issue, that discovery does not in itself make it patent-eligible. He also asserted that the Patent and Trademark Office's recent practice of awarding gene patents was not entitled to deference, in part because the Solicitor General's office, representing the United States, filed a brief in the Myriad case opposing the Myriad patents.

Thomas cautioned that the ruling does not touch on method claims or new applications of knowledge about genes. In a further conclusion that may soften the impact of the ruling on the biotech industry, the court found that synthetic or complementary DNA may be patented because the creator "unquestionably creates something new" that is distinct from the DNA it mirrors.

Reaction is already flowing in on the ruling."We are grateful that the Supreme Court has ruled that naturally occurring DNA segments cannot be patented, said Calaneet Balas of the Ovarian Cancer National Alliance. "Many women we work with are concerned about their genetic risk of developing ovarian cancer, especially in the wake of Angelina’s Jolie’s announcement that she carries the BRCA1 mutation. Myriad’s patent limited women’s options for learning about their genetic risk. Given the deadly nature of ovarian cancer, we are pleased with the Supreme Court’s decision and hopeful that it will give women more options to learn about and safeguard their health.”